# Roflumilast

NDC: 0904-7399
Generic name: Roflumilast
Labeler / Manufacturer: MAJOR PHARMACEUTICALS
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET
Routes: ORAL
Marketing started: 20231226

FDA application: ANDA208256

## Active ingredients

- ROFLUMILAST: 500 ug/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0904-7399"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0904-7399
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c51b80f3-a591-4db9-81b4-b91603e35d7c